The Management of Glucose Control and Hypoglycemic Prevention Using Continuous Glucose Monitoring System in Patients With Type 1 Diabetes

This study was designed to evaluate the glucose control and hypoglycemic prevention effect of using continuous glucose monitoring system(CGMS) in patients with type 1 diabetes. This is a prospective randomized controlled, single-center clinical study. Patients will randomized 1:1 to either CGMS or conventional self-monitoring of blood glucose (SMBG) group. After 12 weeks of applying the CGMS sensors, the improvement of parameters collected from the CGMS will be estimated in comparison with data collected from the SMBG.

Study Overview

• Status: Recruiting
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Device: Continuous glucose monitoring system(CGMS); Device: Self-monitoring of blood glucose (conventional fingerpricking method)

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: EunSeok Kang, Ph.D; Phone Number: +82-2-2228-1968; Email: EDGO@yuhs.ac

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Severance Hospital Diabetes Center, Division of Endocrinology and Metabolism, Department of Internal Medicine, Yonsei University College of Medicine
    • Contact: EunSeok Kang, Ph.D; Phone Number: +82-2-2228-1968; Email: EDGO@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male or female patients ages >= 20 years
2. Patients diagnosed with type 1 diabetes.
3. Patients with glycated hemoglobin (HbA1c) > 8.0% within 6 months before screening
4. Patients who agree to perform self blood glucose monitoring responsibly during the study period
5. Patients diagnosed with type 1 diabetes minimum 3 months prior to recruitment

Exclusion Criteria:

1. Patients diagnosed with type 2 diabetes.
2. Patients with chronic disease (Excluding thyroid disorders in which thyroid function is controlled in the normal range), or psychiatric disease
3. Patients who cannot use the device properly such as an illiterate person or foreigners
4. Patients incapable of making decisions based on their own judgement and will
5. A person who may not participate in the study according to investigator's judgement

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CGMS group; Using continuous glucose monitoring system(CGMS) group	Device: Continuous glucose monitoring system(CGMS); Patients will randomized 1:1 to either continuous glucose monitoring system(CGMS) or conventional self-monitoring of blood glucose (SMBG) group. After the randomization, patients in CGMS group will given education on how to use the device and check the result using the smart phone. The data collected from the sensors were computed to generate the respective ambulatory glucose profiles so as to determine the total numbers of scans conducted during the study period.
Active Comparator: SMBG group; Self-monitoring of blood glucose group (conventional fingerpricking method)	Device: Self-monitoring of blood glucose (conventional fingerpricking method); Patients will randomized 1:1 to either continuous glucose monitoring system(CGMS) or conventional self-monitoring of blood glucose (SMBG) group. After the randomization, patients in SMBG group will check their blood glucose by finger pricking method and record the data in a notebook to share the data in their outpatient clinic visit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change of glycated hemoglobin (HbA1c) level	The HbA1c levels in this study will analyzed twice during the study, once at the baseline and after the CGMS testing was initiated. The improvement of HbA1c level in CGMS group will be estimated and compare it with the change in HbA1c level in the SMBG group.	12 weeks after applying continuous glucose monitoring system

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of participants with improved clinical glycometabolic parameters	Clinical glycometabolic parameters (HbA1c, glycated albumin, glycemic variability, hypoglycemia, calculated insulin dose, patient's self confidence in diabetes self-care, Quality of life) and anthropometric parameters (Blood pressure, Body weight, BMI etc)	12 weeks after applying continuous glucose monitoring system

Collaborators and Investigators

• Sponsor: Yonsei University
• Investigators: Principal Investigator: EunSeok Kang, Ph.D, Severance Hospital Diabetes Center

Study record dates

Study Major Dates

• Study Start (Actual): August 28, 2020
• Primary Completion (Anticipated): June 1, 2022
• Study Completion (Anticipated): August 1, 2022

Study Registration Dates

• First Submitted: December 20, 2020
• First Submitted That Met QC Criteria: December 20, 2020
• First Posted (Actual): December 24, 2020

Study Record Updates

• Last Update Posted (Actual): May 6, 2021
• Last Update Submitted That Met QC Criteria: May 3, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: 4-2020-0831

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No